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Study of Spermatogenesis Suppression With DMAU Alone or With LNG Versus Placebo Alone in Normal Men

NCT03455075 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2025-10-30

No results posted yet for this study

Summary

This is a Phase IIa multicenter, double-blind, placebo-controlled study in healthy men to evaluate the spermatogenesis suppression after oral administration of Dimethandrolone Undecanoate (DMAU) alone or with Levonorgestrel (LNG) for 12 weeks versus placebo alone.

Conditions

  • Healthy
  • Men
  • Male Contraception

Interventions

DRUG

Dimethandrolone-Undecanoate

Single doses of DMAU in castor oil/benzyl benzoate administered in 100 mg capsules.

DRUG

Levonorgestrel 0.03 MG

Single doses of LNG administered in 30 mcg capsules.

DRUG

Placebo oral capsule

Placebo capsules that look like DMAU and LNG capsules but with no active ingredients.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    collaborator OTHER

  • University of Washington

    collaborator OTHER

  • Premier Research

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-16
Primary Completion
2020-03-05
Completion
2020-03-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03455075 on ClinicalTrials.gov